Orthotropic and Orthognathic Oral Device and Method

ABSTRACT

A hygienic oral feed-bottle nipple includes an opening skirt to expand and rotate in the buccal vestibule. As the child completes the suckling cycle, the mouth portion is distorted, the skirt extended to provide cleaning, stimulation, and a bumper to deny extensive pronation. The flanges and skirt may be covered with a textured surface, or bristles, that provide mechanical brushing of oral surfaces. Hard pads set along a superior surface of the nipple are compressed against the maxilla palate and provide upwards and/or lateral force to encourage lateral expansion of the palate. The nipple may be bifurcated into left and right opposing lobes which can split laterally to enhance lateral force on maxilla.

CLAIMS or PRIORITY

The present application includes subject matter disclosed in and claimspriority to U.S. patent application Ser. No. 17/138,831, filed Dec. 30,2020, entitled “Orthotropic and Orthodontic Oral Device and Method”; andU.S. patent application Ser. No. 16/711,128, filed Dec. 11, 2019,entitled “Hygienic and Orthotropic Oral Devices”; and application Ser.No. 16/383,223, filed Apr. 12, 2019, entitled “Pacifier with CleaningBrush” (now U.S. Pat. No. 10,555,876); and provisional patentapplication entitled “Improved Pacifier and Nipple” filed Jul. 11, 2019and assigned Ser. No. 62/872,900; and also PCT application Ser. No.PCT/US20/27279, filed Apr. 8, 2020, all incorporated herein byreference, which describe inventions made by the present inventor.

BACKGROUND OP THE INVENTION 1. Field of the Invention

The present invention relates to the general art of oral care. Thepresent invention more particularly relates to pediatric oralorthotropic development feeding devices and uses thereof.

2. Description of Related Prior Art

A bottle nipple used for feeding, or other devices intended for use in amouth, will be introduced, at least partially, into the oral cavity.Bottles may be equipped with flexible nipples to simulate the naturalskin of a mother's breast nipple, and include one or more boles,channels, and/or pores to allow expression of fluid (e.g., formula,milk, etc.) to the exterior of the nipple surface. Children from the ageof zero to two years+ commonly use oral apparati, such as pacifiers,bottle nipples, teethers, etc. for numerous purposes. In addition tofeeding, these tools may be used to exercise a child's tongue and cheekmuscles, promote development of the maxilla, and otherwise serve toclean interior surfaces of the oral cavity via friction provided by thepacifier exterior surface(s).

Limited inventions have been directed to orthotropics and improvement ofthe development of the upper palate and/or mandible in the developingmouth. Nine out of ten children in the developed world may suffer somelevel of sleep-disordered breathing (SDB) and/or obstructive sleep apnea(OSA), including symptoms from sleep disorders, to breathing issues, togrowth retardation.

While newborns are often born without any erupted teeth, up to 15% ofnewborns in the United Stales have one or more teeth present at birth.The “baby” tooth or teeth may be compromised due to decay caused bybacterial metabolic byproducts such as acids produced from substances inthe oral cavity such as sugars present in milk, formula, or otherwisethe tooth/teeth may be susceptible to damage from bacterial and fungalbiofilms that may develop on the oral surfaces. It is thereforeadvantageous to include an oral apparatus that acts to clean, orotherwise brush, the upper and lower gingival ridges and/or eruptedteeth.

Most oral apparati, such as pacifiers, binkies, soothies, etc., areoften 360-degree symmetrical to mimic the natural human nipple.Oftentimes, a binky, or surrogate nipple. may be uniformly isometric,such as including a cylindrical nub with hemispherical cap (imitating amother's biological nipple). Advanced oral devices may be transverselysymmetrical, left to right, however, may include longitudinal shapechanges such as alternating superior and inferior sides to better mimicthe shape and location of the tongue, and the slight overbite of a baby,newborn, infant, or toddler. The promotion of an ideal orthognathicrelation of the maxillary and mandibular arches, preferably at leastpartially via orthotropic muscular development and pressures, leads tothe better development of tire airway spaces, and this contributes tothe prevention of multiple chronic maladies. As known in the field oforthotropics, deficiencies in airway spaces exacerbate these chronicconditions.

It is therefore a primary object of the present invention to provide anoral device that provides for friction activated cleansing and/orstimulation of interior oral surfaces.

It is another object of the present invention to provide a pacifier tomale with at least one of the superior or inferior ridges (gingivaland/or tooth).

It is yet another object of the present invention to foster properdevelopment of the orthognathic relationship of the upper and lower jawbones.

It is as yet a further object of the present invention to foster properdevelopment of the upper palate and related bone structures.

It is a further object of the present invention to provide aneasy-to-use oral device useful for babies and/or small children.

These and other objects of the present invention will become apparent tothose skilled in the art its the description thereof proceeds.

SUMMARY OF THE INVENTION

The present inventions directed to a bottle-feed nipple device adaptedto be at feast partially inserted into the oral cavity and form aresting shape when at rest and a compressed form when under pressurefrom either compression of a nipple, collar, and or neck of the device.The device includes a nipple bulb set on a posterior end of the device,a collar joining with a skirt and a neck along an anterior end of thedevice. Preferably the neck and/or interior end are couple to a feedbottle. The nipple bulb has one or more pore(s) along a posterior outersurface of the bulb. The bulb also includes a pair of laterally opposingpads set along a superior surface of the bulb, with a central cleft setbetween the pair of laterally opposing pads. The bottom of the bulb mayinclude a longue guide as a depression along an inferior surface of thenipple bulb. The tongue guide may be defined by one or more or acontinuous encircling ridge. Preferably, an inferior lingual ridgedefines a posterior edge of the tongue guide.

The device may also include a superior skirt coupled anterior of thenipple bulb, the superior skirt having a bumper edge along the tip(s) ofthe skirt. The device may also include an inferior skirt coupledanterior of the nipple bulb.

The device may have resting shape and a compressed shape. The restingshape includes the superior and inferior skirts at a first narrow anglerelative a center line set horizontal and longitudinally through thedevice, with the pair of laterally opposing pads in a first position.The device forming a compressed state external pressures are appliedagainst the nipple bulb (by the tongue and/or roof of mouth), at acollar via one or more alveolar ridges and/or at the neck by one or morepursing lips. The superior and inferior skirts are rotated to a greaterangle and the pads are forced laterally apart in the compressed state.

The present invention is also directed to an oral device adapted to bepartially inserted into the oral cavity. The present invention may takethe form of a bottle nipple, or otherwise. When functioning as a bottlefeed nipple, a single molded piece is preferred to fit over an open endof a bottle.

The upper portion of the intra oral device may include a solid and/orflexible padding with one or more materials. Harder or thicker, those ofa higher durometer, portions of the dome (or pads) may be separable, orat least change their relative orientation, as a central materialstretches. As the sucking motion is conducted, a tongue pressure pushesup on the bottom of the nipple (preferably at the tongue guidedepression) and causes lateral stretching of the device. As the deviceis stretched, the harder/thicker portions at the top side resiststretching and are thus thrust against the upper plate and cause aslight upward and laterally outward force. The lower portion includes atongue depression, preferably a concentric circular or toroidalextension guide, to better ensure proper alignment of dive with thecenter of mouth and tongue. The outer surface of the device may includebristles, or a spiral shape for cleaning purposes, often as rubbedagainst surfaces of the mouth.

A nipple version of the present invention may include variousundulations, and/or ribs, to cause proper turbulence of flowing fluids,to provide stimulation/cleaning to the oral surfaces, and to preventvacuum seals on the mouth surfaces, and avoid hematomas. Turbulence mayinduce micro vibrations that stimulate growth plates and suture platesin the tissues and hones along and within oral surfaces. The angle ofthe pronation of the teeth and/or alveolar ridges is controlled andprevented from exceeding certain thresholds, e.g. 20° pronation that cancause adverse deformation of the malleable (growing) jaws. Further, thesuperior and inferior edges of the device, preferably at the collar, areoffset with the superior set slightly (e.g. 1-3 mm) forward relativelive interior collar to promote proper orthotropic and/or orthognathicalignment of the maxilla and mandible relative the skull.

A shell of the nipple may include an outer surface that has surfacefeatures, such as a texture, fingers, bristles, etc. The texturedsurface may be set in direct contact with the alveolar ridges (eitherbare gums (edentulous), or with erupted teeth). In alternativeembodiments, the textured surface may also extend along the inferiorsurface of the nipple and bulb to provide for cleaning of the top of thetongue, and along superior surface to clean the roof of the mouth/hardpalate.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described with greater specificity andclarity with reference to the following drawings, in which:

FIG. 1 illustrates a side cross-sectional view of an embodiment inpassive state as applied into a human mouth.

FIG. 2 illustrates a side cross-sectional view of an embodiment in acompressed state as applied into a human mouth.

FIG. 3 illustrates a side cross-sectional view of the mouth portion inpassive state of an embodiment of the present invention.

FIG. 4 illustrates a frontal view of a nipple in passive slate of anembodiment of the present invention.

FIG. 5 illustrates a side cross-sectional view of the mouth portion incompressed state of an embodiment of the present invention.

FIG. 6 illustrates a frontal view of a nipple in compressed state of anembodiment of the present invention.

FIG. 7 illustrates a top view of a mouth portion in passive state of anembodiment of the present invention.

FIG. 8 illustrates a frontal view of a nipple and skirt in passive stateof an embodiment of the present invention.

FIG. 9 illustrates a cross-sectional side view of a skirt and collar inpassive state an embodiment of the present invention.

FIG. 10 illustrates a top view of a mouth portion in compressed slate ofan embodiment of the present invention.

FIG. 11 illustrates a frontal view of a nipple and skirt in compressedstate of an embodiment of the present invention.

FIG. 12 illustrates a cross-sectional side view of a skirt and collar incompressed state an embodiment of the present invention.

FIG. 13 illustrates a side view of an embodiment of the presentinvention.

FIG. 14 illustrates a perspective view of an embodiment of the presentinvention.

FIG. 15 illustrates a top view of a mouth portion of an embodiment ofthe present invention.

FIG. 16 illustrates a frontal view of a mouth portion of an embodimentof the present invention.

FIG. 17 illustrates a bottom view of a mouth portion of an embodiment ofthe present invention.

FIG. 18 illustrates a perspective view of a mouth portion of anembodiment of the present invention.

FIG. 19 illustrates a side cross-section view along lines A-A of FIG.16.

FIG. 20 illustrates a side cross-section view along lines B-B of FIG.16.

FIG. 21 illustrates a side cross-section view along lines BB of FIG. 16as when the mouth portion is in a compressed state.

FIG. 22 illustrates a side view of a mouth portion of an embodiment ofthe present invention.

FIG. 23 illustrates a front cross-sectional view along lines C-C of FIG.22 in passive state.

FIG. 24 illustrates a front cross-sectional view along lines C-C of FIG.22 in compressed state.

FIG. 25 illustrates a side cross-sectional view of an embodiment incompressed state with force vectors of flow and external pressures.

FIG. 26 illustrates a front view of an embodiment in passive state.

FIG. 27 illustrates a partial transparent side perspective view of analternative bottle embodiment in passive state as applied into a humanmouth.

FIG. 28 illustrates a side cross-sectional view of an embodiment inpassive state.

FIG. 28A illustrates a side cross-sectional view of an embodiment inpassive state.

FIG. 28B illustrates a side cross-sectional view of an embodiment incompressed state.

FIG. 29 illustrates an underside of an embodiment of the presentinvention.

FIG. 30 illustrates an underside of an alternative embodiment of thepresent invention.

FIG. 31 illustrates an underside of an alternative embodiment of thepresent invention.

FIG. 32 illustrates a frontal view of a posterior end of an embodimentof the present invention.

FIG. 33 illustrates a top side view of the embodiment of FIG. 31.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With use of embodiments of the present invention, one may providehygienic and/or orthotropic support to newborns, infants, children,adolescents (or even adults). The present invention maybe used toprevail adverse deformation of the tissues and bones associated with themouth. When used in newborns and infants, the application of orthotropicdevices can guide the eruption of teeth and position and orient thebones in an ideal position. Further, via application of rhythmicvibrational signaling, stem cells can be activated, and causingphenotype improvements via epigenetic expression guided via externalstimulation of the genotype. Rhythmic vibrational signaling can increaseor induce stem cell development in the area of the signal.

Proper orthotropic development may also have multiple other pathways forproviding a healthier human, both aesthetically and for health factors.Obstructive sleep apnea affects millions of people of all ages. Inchildren, symptoms can range from bed wetting, choking, drooling,coughing, night sweats, behavioral problem, learning disabilities,sluggishness, snoring, teeth grinding, restlessness, attention deficithyperactivity disorder (ADD or ADHD).

By forming an orthotropically aligned mouth, with proper basalpharyngeal anatomy, a root cause of sleep-disordered breathing andobstructive sleep apnea (OSA) can be minimized, controlled, or eveneliminated. With the present invention and embodiments thereof, we maycontrol or prevent these chronic and debilitating diseases.

An embodiment with discreet ribs can be seen in FIGS. 13-15, wherebottle 1 may be equipped with cap 2. Bottle 1 is shown with cap 2 atposterior end of the bottle. Mouth portion 3 is set on posterior of cap,and includes skirt 27 and nipple bulb 5. Cap 2 may be threadedly engagedto screw onto bottle 1. Month portion 3, fits onto cap 2, preferably viaa channel lip fastening connection as shown below in FIGS. 15-22. It ispreferable that cap may be removed from bottle via unscrewing, andnipple may be removed from cap, to facilitate cleaning of the bottle andcomponents. Cap is preferably made of a hard plastic, while nipple ispreferably made of a softer plastic, silicon, rubber, silicone, or otherknown material for nipples, bottles, and pacifiers. Nipple bulb 5 mayinclude air vent 29, preferably set outside area of tips when in use (asshown in FIG. 28). Air vent 29 is preferably set on top of tire nipplesurface, or along superior surface 129.

As shown in FIG. 20, a one-way valve 90 is preferably set on mouthportion 3 to prevent backflow of fluids posterior of the valve to flowback into the bottle. Valve 90 further increases the pressure on theposterior end (nipple end) to assist in expression of fluids throughpore(s), and to increase pressure on skirt 27 to cause full expressionof skirt and enhance rhythmic vibration us fluid turbulently moveswithin mouth portion Skirl and nipple bulb 5, especially along interiorof skirt(s) major and/or minor undulations and bumper edge.

With reference to bottle mouth portion 3 in use with a human mouth.FIGS. 1-2 demonstrate two states of action. FIG. 1 demonstrates themouth portion 3, including skirt 27 and nipple bulb 5 applied to a humanmouth prior to application of compressive forces. This is termed thepassive state, as equilibrium forces within and outside the mouthportion, the structure, shape, and orientation remain in passive form.Upper lip 10 and lower lip 11 of the user may fit onto neck 4 of mouthportion, with neck acting as a lip hold. Superior and inferior alveolarridges 12 and 13 bite down on collar 8. Major undulations 6 may beprovided opposite bottle posterior neck 4. Major undulations, includingboth superior major undulation and inferior major undulation 6A and 6B,are preferably set to fit into the maxillary buccal vestibule 16 andmandibular buccal vestibule 17, respectively, when in compressed form(as shown in FIG. 2). Minor undulations 7, fit along/between majorundulations (as shown) and are set anterior the bulb of main nipple atcollar 8. Together, the major and minor undulations form ribs (radiallyemanating and/or vertical structure of ribs described below). Tongue 19presses upwards on guide 21, to squeeze bulb 5 and force bulb 5 todeform and extend into oral cavity 18.

When sucking, ribs and minor undulations encourage turbulence of fluidflowing within mouth part, and further prevent vacuum seal against oralsurfaces. Ribs further allow expansion of the flanges of the skirt toexpand outwardly from center line 50 (shown in FIGS. 28, 28A, and 28B,below) to fill in portions of the vestibules. Lips wrap around neck,potentially forming a fluid tight seal. Lips purse to cause skirtdeformation. Lips press neck via the user's orbicularis oris musclesqueeze the neck forcing skirt to extend and/or rotate outward to fillthe vestibules (superior and inferior). Sucking force propels nipplebulb 5 posterior into throat extending the bulb and deforming it on thelongitudinal direction, and often flattening the bulb viaupward/anterior tongue pressure. When suction action is release,material retractive forces from shape memory in the nipple system allowthe bulb to reform and retract, the skirt to close and return and thesystem to reshape as in resting form.

Ribs, allow for mechanical cleaning of gums and alveolar ridges,particularly as the nipple is mechanically moved within the oral cavity.Micro-movements of the undulations may cause a rhythmic vibration, andvibrational signaling, on the oral surfaces to stimulate vasculardevelopment, tooth growth, and stem cell growth in the bony membrane andbone development/production. Undulations (major and minor) may form askirt 27, while major undulations help define a skirt edge 47, thatprovides for a bumper. As skirt 27 expands in compressed form, skirtedge 47 forms a preferred angle 34 of ten to twenty degrees from centerline 50 to prevent excess pronation of the alveolar ridges to go beyondtwenty-degrees from vertical axis 30 (or seventy degrees from horizontalplane 50). By capturing the alveolar ridges between the skirt and nipplebulb 5 surface (as shown prominently in FIG. 2), the pronation of thealveolar ridges can be guided by the geometry of the nipple in expandedform (in accord with compressed slate of nipple, the terms “expanded”form and “compressed” used interchangeably to refer to the stat ofnipple when bulb compressed by tongue during normal use).

As shown in FIGS. 28, 28A and 28B, vertical axis 30 and horizontal plane50 meet at vertices 75 and 85, while skirt 27 is intended to roughlyrotate along vertex from a more acute angle, as shown in FIG. 28A, tothe wider acute angle 34, as shown in FIG. 28B, when exposed tocompressive forces to achieve the compressed state (discussed below withreference to FIG. 2). As mandible 15 rises with chin 25 to close mouth,alveolar ridges engage collar to “bite-down” on nipple collar. Nipplebulb 5 may include milk pore 26 at the proximal (or posterior) end ofnipple. Milk pore can be one or more apertures in the nipple, dependenton the needed flow rate for feeding in relation to the age/size ofinfant/user. Superior vertex 75 is set anterior of inferior vertex 85 bydisplacement offset 33 for proper orthognathic alignment of the jaws.

As understood in reference to earlier FIGS. 1-3, between undulations andnipple, a collar 8 is formed. Collar 8 provides placement for maxillaryalveolar ridge and mandibular alveolar ridge, respectively. Maxillaryalveolar ridge 12 fits onto superior nipple collar, while mandibularalveolar ridge 13 fits into inferior nipple collar. An inferior lingualridge 9 may be set as between collar 8 and a depressed tongue guide 21.Tongue guide is preferably formed as an inferior extending toroidalportion, or donut, either concentric or oval or other contained shape,forming a lingual donut with extending portion 122 isolating an interiormaximal point 121 to guide the tongue tip or superior surface of thetongue into guide 21 (as show n in FIG. 29). Tongue guide 21 providesfor a depression to help locate tongue 19. Tongue guide also causestongue to provide upward force against maxilla, and otherwise exerciseand develop habits to strengthen and encourage proper tongue placementwhen not feeding/using device, and trains the tongue positioning from anearly age. Nipple bulb 5 superior surface 129 fits into vault 20 ofuser's mouth 5.

As seen in FIGS. 2 and 25, the sucking action caused deformation ofmouth portion 3 into a compressed state. Force vectors are shown viaarrows. Lips 10 and 11 press, to provide push vector compressive forcesagainst superior and inferior neck 4, respectively (neck 4 providing alip hold). Upper and lower skirt, 27, expand, rotate, and move to fillmaxillary and mandibular buccal vestibules, 16 and 17. Maxillaryalveolar ridge 12 and mandibular alveolar ridge 13 engage collar 8 tobite down onto mouth portion 3. Tongue 19 further presses upwards andanteriorly into tongue depression guide 21 to press on, or squeeze,nipple bulb 5. When feeding, the mouth serves to suck on nipple in aposterior direction (e.g. as when feeding) to pull nipple back intomouth. As mouth portion 3 is deformed, nipple bulb 5 extendsposteriorly, and skirt 27 extends outwardly (up and down).

As can be seen in FIGS. 3-6, mouth portion 3 in passive (non-compressed)state is shown in FIGS. 3-4, while in compressed state in FIGS. 5-6. Airvent 29 is set along neck 4 in proximity to cap 2 (not shown). Majorundulations 6 are shown extending at offset extending lengths to formskirt 27, with minor undulations 7 set between major undulations 6 andcollar 8. As is shown in FIG. 28, superior and inferior collars 8 areoffset by linear offset 33 which may be as much as 1-3 millimeters tofrom an orthotropic collar to guide jaw relationships, to optimizepositioning as known in natural breast feeding, and facilitate properorthotropic and/or orthognathic jaw development. It is contemplated thatpositioning the superior maxilla, forward by 1-3 millimeters in relationto the inferior mandible, proper alignment of the jaw will be formed.Superior collar 8A may be set 1-3 mm anterior relative inferior collar8B to enhance orthotropic/orthognathic jaw relationships.

As can be seen, in FIGS. 28, 28A and 28B, vertical axis 30 designates atwenty-degree angular offset 34 from vertical 30, both above and belowcollars. When viewed relative the horizontal plane 50, extended skirtdesignates a seventy-degree offset, as the threshold angle to which thepronating alveolar ridge is abutted and stopped from further pronation.It is contemplated that the angle of the alveolar ridges when engagingthe collars will limit the forward pronating angle to twenty degreesfrom vertical as is shown in angle 34. The angle of twenty degrees fromvertical, or seventy degrees from horizontal, is preferred as themaximum orthotropic angle for forward extension of the alveolar ridgesand teeth as they emerge. This is in contrast to development of pronateteeth caused by thumbsucking, etc. as is known in the art of pediatricorthodontics. Angles less than twenty degrees are preferable, while anangle between fifteen and twenty degrees is most preferable. Anglesbeyond twenty degrees would indicate excessive pronate tooth/ridgegrowth and is prevented by the extending undulations.

FIGS. 28A-28B demonstrate passive and compressed states of nipple. Inpassive state, as shown in FIG. 28A, skirts 77 and 87 form a more acuteangle relative horizontal line 50. Additionally, collar 8 is offset at alower length of approximately 0-1 mm. As mouth portion 3 is exposed 10compression forces, skirts 77 and 87 expand as minor undulations 7flatten out to allow major undulations 6 to rotate and extend (so as tofill buccal vestibule). Skirt may be outfitted with surface featuressuch as bumps or texture. Skirt 27 includes upper skirt 77, whichextends to an angle of approximately twenty degrees from vertical, asdefined from superior vertex 75 defining an upper vertical axis 76, andlower skirt 87, which extends to an angle of approximately twentydegrees from vertical, as defined from inferior vertex 85 defining aninferior vertical axis 86.

Referring to FIGS. 26-27, an embodiment with continuous or solid skirtis shown. Skirt 27 frenum relief 28 is shown, the device including bothsuperior and inferior frenum reliefs 28. Solid ribs 48 are joined byskirt web 148. Undulations together each form a vertical or emanatingrib. Each rib 48 may include a major bump on the end to form the skirtedge bumper 47, and a minor extension, minor undulation 7, that maycontact the alveolar ridge/gum.

Referring to cross-sectional views of line 4-4 in FIG. 3, FIGS. 4 and 6demonstrate interior of nipple wherein nipple bulb 5 may includeobstructive sleep apnea (OSA) pads 24. Pads, referring generally tofeatures on the bottle feed nipple and pacifier nipple, refer tointegrated and/or alteration of thickness of one or more regions of thesuperior side of the nipple and/or nipple shell wherein one or moreregions of the nipple walls/shell may include material, or be reinforcedwith material of at least one different durometer material as comparedto another region of the nipple shell/walls. Pads are preferably fixedrelative the nipple bulb 5 shell on the superior and/or side surfaces,preferably the superior surface. Pads preferably have a higherdurometer, or are stiffer, than the general nipple material. Pads may beintegrated on the inside of one or more regions of a shell of thenipple. Pad(s) may be made of the same material as flic rest of thenipple, or not. Different materials may be used, or different durometersof the same material, to achieve desired forces. Pads may includedifferent synthetic materials to allow for greater or less elasticity orflex. The pads, or the superior surface of the nipple may include atexture integrated into the upper wall of the nipple. In someembodiments, the materials of the nipple are identical throughout. Inother embodiments, the materials may vary where pads are integrated(e.g., in the inside upper portion of the nipple). In furtherembodiments, the material of the nipple may differ from the material ofthe shield and/or flanges, in whole or in part. Preferably pads are of ahigher (harder) durometer than other portions of the nipple, such as thefrenum, posterior end, inferior side, lateral sides, and or neck. Whilepads are referred to as OSA pads, the general nature of the pads causinglateral (and potentially secondary upwards) force is to providetreatment or prevention of a number of disorders associated with araised/narrowed maxillary vault, including OSA, crowded teeth, narrowjaw, muscle disorders, etc.

The pads 24, may include separable right 24A and left 24B pads that areadapted to engage the maxilla of the user mouth, and apply small forcesto achieve ideal orthotropic growth of maxilla. Internal padding of OSApads provide for posterior and lateral forces when engaging maxilla, andprovide treatment for maxillary bone development to encourage wideningof maxillary sutures or suture lines. By stretching suture lines toincrease surface area of maxilla and volume of the arch, the maxilla isextended laterally and anteriorly. Further, the nasal pharyngeal anatomyis expanded to facilitate breathing. This widening and growth of theorthognathic structures reduces risks and effects of SDB and obstructivesleep apnea.

Set between right and left OSA pads 24A and 24B is center cleft 45 thatmay bisect OSA pads along longitudinal plane 124. OSA pads may include acleft 45 along plane 124 that may connect OSA pads either along nipplebulb 5 shell 106, or include a rigid material joining both OSA pads.

OSA pads 24 may include two separate pads, as shown, and milk pore 26may include one or more holes, or separate openings (as shown in FIG.26), to allow for fluid passage from bottle through nipple. OSA pads 24are preferably thicker pads that allow lateral expansion to aid inorthotropic development of the maxilla and nasal floor. OSA pads 24press and separate to force expansion of the maxilla. Employing lateraloutward pressure on the maxilla, encourages broadening the maxilla, thuscausing opening the floor of the nose. This well-developed maxilla andnasal floor provide proper aeration through the nostrils, and increasesventilation through the nose to decrease harmful issues associated withasthma and allergies. Nose breathing helps warm incoming air, filter theair, and mixes nitric oxide (a potent vasodilator) to be received by thealveoli in the lungs. This in tum causes better oxygen absorption andraises oxygen saturation in the blood. Further, with properstretching/growth of the appropriately widened maxilla throughorthotropics, the mandible will be induced to expand to a proper widthas well in accordance with widening of upper teeth/ridge in maxilla.Compressive forces applied (by the mouth) force down on roof of nippleas the infant feed. Compressive forces are also applied to the interiorside by the infant's tongue, and fluid is forced from pore. Superior andlateral forces on nipple/mouth portion are applied to create maxillaryorthotropic forces in resistance via OSA pads, and guide bettermaxillary bone development. The proper nasal pharyngeal anatomy reducesthe risk of sleep issues and OSA. (Note: passive state shape is shown inbroken lines to mark dynamic change in mouth portion shape.)Additionally, if the OSA pads are used to exert a widening/sidewayslateral outwardly force that widens the maxilla, one may prevent ortreat issues wherein the vault is widened and thereby lowered reducinglift on the vomer and anterior nasal spine, thus preventing risingforces against the ethmoid bone. The lateral maxillary bones areflattened and spread, preventing upwards force on the growth of thevomer. By widening the two maxillary plates, potential growth of thevomer will reach its vertical peak without colliding with the ethmoidbone, thereby decreasing the chance of developmental deviated septum.

In all embodiments, the OSA pads may be a hard or soft solid, gel orotherwise material as known in the art for oral treatments, such assilicone, rubber, plastic, calcium, silver, zinc, or otherwise. Further,the OSA pads may be self-contained fluid sacs filled with a water, ormore viscous fluid to soften the impact on the maxilla, upper palate.The OSA pads may be filled with a fluid that contains non-dissolvedparticles that provide for minor vibrations as the OSA pad sac ismanipulated (or changes shape). Further the OSA pads may be in fluidcommunication with a fluid filled bladder, such that compression of thebladder forces fluid into the OSA pad sacs.

As can be seen in FIGS. 3 and 5, mouth portion 3 is shown. Air vent 29is preferably placed on superior side 129 on the anterior edge 103 ofmouth portion 3, near where mouth portion meets cap (not shown here).Minor undulations 7 provide for a zone of undulation that can stretch orotherwise add to turbulence of flowing fluid. Nipple bulb 5 extendsposteriorly from orthotropic collar 8, and further include tongue guide21. Collar 8 includes an offset, whereby skirt superior rib is setforward (or anterior), approximately 1-3 mm relative skirt inferior rib.The offset of the collar and ribs is associated with proper orthognathicalignment of the jaw.

As can be seen in FIG. 5, a fluid flow design is shown. Multiple forcevectors induce distortion and migration of major undulations 6 to createflaps that fill the maxillary and mandibular buccal vestibules. Air vent29 is set outside of user lip to allow a one-way valve flow of air intothe bottle so as to prevent vacuum within the bottle. Air vent ispositioned in a manner that shall be preferably on the superior side ofnipple, but may be on the inferior side. Both push and pull forcevectors impact the mouth portion and nipple Push forces are provided bythe compressive motions, such as lips pursing and alveolar ridges/teethbiting against the upper and lower portions of the device, further, thetongue pressing upwards causes a push force vector against the nipple,further distorting the shape. Pull vectors are provided by the suckingand vacuum forces that draw fluid from the bottle through the pores andair into the vent. Further, pull vectors cause the nipple to stretch,with the bulb elongating in a posterior direction, causing the skirl toopen to a more upright and vertical orientation, and top of bulb maymeet the roof of the mouth vault.

It is preferable that the air vent 29 prevents fluid exiting air vent.As the force vectors engage the nipple, the lips purse around neck 4,and alveolar ridges rest along collar 8 and may squeeze. Maxillary andmandibular alveolar ridges engage collar 8 to further squeeze nipple andsecure relative position of nipple in oral cavity. Finally, suckingforce induces a pull or vector force towards the throat. Sucking issupported by tongue thrust from tongue 19, preferably at tongue guide 21on the inferior side of nipple. OSA pads 24 are forced up against themaxilla. Fluid flows out of bottle and through milk pores 26. The pathof flow is guided via the shape of the nipple as it is deformed.Undulations 6 and 7 extend into vestibules causing a broadening of thenipple. Fluid flows from bottle into undulations of skirt 27 and causesturbulence within undulations. This turbulence is preferred to preventsolids from forming, and otherwise as a hygienic cleaning function toprevent buildup of residue, or otherwise stagnant fluid. As theundulations are flushed, fluid continues to flow into nipple, inturbulent fashion until reaching release at milk pore 26. Both therepetitive swallow action and rhythmic vibrational signaling induce stemcell activity.

As shown in FIGS. 15-19, major undulations 6 form a skirt 27 and bumper47. Nipple bulb 5 includes tongue depression guide. The mouth portionincludes air vent 29 and channel 105. Channel is set to allow screw cap2 (not shown) to fit via fastening method over mouth portion.Preferably, cap includes an extending interior flange to fit intochannel, while mouth portion is made of a flexible material that cansqueeze into cap. As can be seen in FIG. 6, OSA pads 24A and 24B are setwith a superior cleft 45 set therebetween. OSA pads are preferably of athicker material, and cleft allows for relative movement of OSA pads todeform flex and bend as the nipple is deformed under pressure, tonguedepression guide 21 is shown along with a single milk pore 26. Theclefting of the internal OSA pads will, upon tongue compression, causelateral and superior loading of the two maxillary membranous bonyplates.

Various shapes of the mouth portion 3 are shown in FIGS. 7-12. FIGS. 7-9show the mouth portion in passive state (when equilibrium forces are setupon system). Skirt 27 includes frenum relief 28 to engage with theuser's mouth. Skirt 27 is shown closed, and nipple bulb 5 is intruded.Major undulations 6 form skirt 27 and edge 47. Major undulations 6 andminor undulations 7 forms ribs 48. Skirt may form a flat angle at rest.FIGS. 10-12 show the system in compressed form. Nipple bulb 5 isextended (posteriorly) forced by compressive forces and/or suckingvacuum (pull) forces. Skirt 27 flares out as neck 4 is squeezed by lipsto provide lateral opening of skirt, Nipple bulb 5 stretches andextrudes. Ribs 48 are also stretched and reach a low angle profile. Whenribs and skirt flare out, skirt fills buccal vestibule. Skirt increasesin height, narrows (as minor undulations flatten), and turns upright.Skirt 27 also provides a bumper of sort to help guide orthotropic angleof alveolar ridge—preventing excessive pronation. Skirt may form a highangle, approximately twenty degrees, preferably to manage pronation ofteeth, as discussed herein.

Mouth portion 3 is shown in isolation for further detail of anembodiment of the present invention in FIGS. 15-24. Mouth portion 3includes circumferential features on anterior side 103, including edgeflange 101 and secondary flange 102 forming channel 105. Channel 105mates with interior flange in cap (not shown) to provide a flexible, yetwater-tight seal when mouth portion applied to cap. Skirt 27 forms withmajor undulations 6. In this embodiment with discontinuous skirt 27, itis preferred that an even number of major undulations 6, and ribs 48,are formed with a center gap 46 set therebetween on both superior andinferior sides. Center gap 46 acts as frenum relief. Center gap mayserve as frenum relief. Nipple bulb 5 includes pore 26, or pores inalternative embodiments. Skirt 27 defines side edges 57, absent ofundulations. Nipple bulb 5 includes tongue depression guide 21 on theunderside of nipple as a sort of lingual hemi-torus. Tongue depressionguide 21 forms an inverse saddle point 121 (mathematical) whereby alocal maximum is formed in the underside surface of nipple towardscenter of tongue guide 21. Tongue guide anterior lingual ridge gentlyforces the mandible forwards as the sucking motion occurs.

Mouth portion 3 may include interior separator 90, that can function toprovide fluid impermeable material to prevent flow of fluids back intobottle. Separator 90 is preferably planar and extended along interiorsurface of mouth portion. One or more one-way fluid valves 91 may beemployed to function both as a one-way valve to prevent flow of fluidsback into bottle as nipple is depressed, and further serve to increasehydraulic pressure within the mouth portion nipple bulb 5 and skirt toenhance deformation, and further increase force applied by the pad(s) onthe arch and skirt against alveolar ridge(s). The closed valve also maycause movement of fluids within mouth portion structures to follow pathsaround perimeter of mouth portion to cause specific flow paths that mayin turn yield vibrations that can enhance growth factors. One-way fluidvalve increases fluid pressure in the nipple chamber after the firstsuction event occurs to retain fluid in the nipple and thereby maintainpressure via OSA pads against maxilla.

One-way fluid valves 91 are preferably set along interior edge 92 ofmouth portion 3 at perimeter. Further, pads 24 are set preferably within(as shown, or part of the features of the nipple shell, or lesspreferably on the exterior surface of nipple shell (not shown)). FIG. 21shows feed fluid paths. As shown in FIGS. 23-24, nipple bulb 5 movesfrom passive state (FIG. 23) to compressed state (FIG. 24). Tongue guide21 is forced upwards and further distorts nipple to cause pads 24 a and24 b apart. (Superior) cleft 45 allows for mechanical separation androtation of pads. As shown in FIG. 21, fluid flow path is indicated byarrows, fluid entering mouth portion 3, passing through skirt (causinginterior flushing/cleaning and causing vibrations) around pad 24 and outpore 26.

FIG. 25 further demonstrated the multiple force vectors caused when inuse by user's mouth to distort and reshape mouth portion 3 on cap 2.Force vectors induce distortion and migration of skirt (or flaps) andalso produce turbulence of flow through mouth portion 3. Pursing of lips10 and 11 around neck 4 cause compressive force. Alveolar ridges 12 and13 bite down on collar 8. Tongue 19 provide thrust up against longueguide 21 and compresses against maxilla vault 20.

The present invention is also directed to an orthognathically correctedfeed nipple that serves multiple purposes. The device isorthognathically positioned to help nurture the jaws grow into a betteralignment. Under standard operating protocols, the invention provides amethod for feeding and maintaining oral hygiene. As suckling isconducted, the nipple may be compressed by external forces applied bythe patient's oral muscles. The suckling motion causes the nipple tocompress and extend posteriorly into the back of oral cavity and/orthroat. As the feeding suckling takes place, the skirt rotates outwardly(and anteriorly) to engage the alveolar ridges and/or vestibules. As theskirt rotates, the minor undulations may contact, and move against (orbrush), surfaces of the oral cavity.

As is shown in FIGS. 29-32, posterior end 205 may be bifurcated as lobes205A and 205B separated, with interlobe webbing 206 therebetween. Mouthportion 3 includes neck 4 skirt 27 bulb 5 with tongue guide 21 pads 24and pore 6. Crevasse 271 forms where lobes mate, and crevasse 271 ispreferably set posterior of tongue guide 21 and of posterior inferiorlingual ridge 9. Lobes 205A and 205B split in center 207. Lobes may bemade of a high durometer material to maintain the shape of the entirelobe, or more preferably the upper surface of lobes retains shape as thenipple 355 is lateral expanded. Lobes maintain shape as pressed upagainst maxilla to cause outward-lateral and upward forces on maxilla.

Bulb with or without bifurcated lobes or solid shape (as describedabove), various shapes and contours of tongue guide may be incorporated.Tongue guide 21 includes posterior inferior lingual ridge 22 andanterior inferior lingual ridge 23 and lateral ridges 107. Tongue guide21 may form a hemi-torus shape with lateral inferior lingual ridges 109on either side of tongue guide 21 as shown in FIG. 30. Tongue guide 21may include an inverted saddle point 221 as a local high point in guide21. Depending on user preference or orthognathic requirements, thetongue guide may form various shapes. As shown in FIGS. 29 and 31, thetongue guide may include a flattened ridge, deviating from a concentrictoroidal portion. The tongue guide may form a rounded triangular shape.As shown in FIG. 29, posterior ridge may be flattened to broaden theposterior ridge and enhance mandibular anterior forces, such as tocorrect an overbite when sucking. Alternatively, as shown in FIG. 31,the posterior ridge may be narrowed and the anterior ridge flattened.This may be useful to correct an underbite.

Thrust by user's tongue may be pressed up into guide 21 and outward toall inferior ridges 22, 23, and 109, further forcing lobes 205 apart.One advantage of this, and other embodiments, is that as the oral deviceis compressed, the nipple is extended posteriorly into the oral cavity(towards throat) so that pads can engage deeper (more posterior) againstmaxillary palate, allowing lateral pressures to press against anteriorand posterior maxillary palate.

In some embodiments, pads may be set upon outer surface of shell asprovide external bumps. Preferably, the pads are set within the bulb orreplace portions of the nipple shell. As the nipple is compressed, padsmigrate with shell of nipple, as nipple is compressed and flattened, toorient against left and right maxillary plates of the mouth upperpalate. While pads are initially set next to, or near one another alongsuperior, as the nipple is compressed, upward forces on bottom of nipplealong with other forces, cause the compressed nipple to extendlaterally, moving pads laterally apart from one another. In thisembodiment, pads may not be bound by central cleft, and instead may beseparable features.

I claim:
 1. A bottle-feed nipple device adapted to be at least partiallyinserted into the oral cavity and form a resting shape when at rest anda compressed form when under pressure from either compression of anipple, collar, and/or neck of the device, said device comprising: anipple bulb set on a posterior end of the device, the nipple bulbcomprising a pore along an outer surface, and a pair of laterallyopposing pads set along a superior surface of the bulb, with a cleft setbetween the pair of laterally opposing pads, and a tongue guide as adepression along an inferior surface of the nipple bulb with an inferiorlingual ridge defining a posterior edge of said longue guide; a superiorskirt coupled anterior of said nipple bulb, said superior skirtcomprising a bumper edge along a lip of the skirt, and an inferior skirtcoupled anterior of said nipple bulb; said device having a resting shapeand a compressed shape, wherein resting shape comprises said superiorand inferior skirts at a first angle relative a center line sethorizontal and longitudinally through said device, and said pair oflaterally opposing pads in a first position; said device further havinga compressed state, said device forming said compressed state whenexternal pressures are applied against the nipple bulb, at a collar viaone or more alveolar ridges and/or a neck by one or more lips; saidcompressed state comprises said superior and inferior skirts at a secondangle relative the center line, and said pair of laterally opposing padsin a second position; wherein said second angle is greater than saidfirst angle, and said second position comprises said pair of laterallyopposing pads further from one another in a transverse direction.
 2. Anoral device adapted to be at least partially inserted into the oralcavity, said device comprising: a nipple with a pair of pads laterallyarranged relative one another along a superior surface of a bulb of saidnipple, said pair of pads with a first pad on the right and a second padon the left with a cleft set therebetween; and wherein said nipple isadapted to form a resting shape and a compressed shape, said compressedshape comprising expanded positioning of said pair of pads laterallyfurther apart one another relative a contracted positioning in a restingshape.
 3. The device as set forth in claim 2 wherein said nipple bulbcomprises a posterior end with a bifurcated dual lobe nipple system, anda vertical indentation on the posterior end of said nipple bulb.
 4. Thedevice as set forth in claim 3 wherein said bifurcated dual lobe nipplesystem comprises a first right lobe supporting the first pad and asecond left lobe supporting the second pad.
 5. The device as set forthin claim 4 further comprising a tongue depression guide on an inferiorsurface of said bulb, said guide as an inverted depression defined by ananterior inferior lingual ridge, a posterior inferior lingual ridge anda lateral interior lingual ridge.
 6. The device as set forth in claim 2further comprising a superior skirt extending from said nipple, saidsuperior skirt adapted to rotate to an anterior and/or upward positionwhen said nipple is in the compressed state.
 7. The device as set forthin claim 6 wherein said superior skirt comprises a central frenum reliefas an indentation along an edge of said superior skirt.
 8. The device asset forth in claim 6 further comprising an inferior skirt extendinginferior of said nipple, said inferior skirt adapted to rotate to ananterior and or downward position when said nipple is in the compressedstate.
 9. The device as set forth in claim 8 wherein said inferior skirtcomprises a central frenum relief as an indentation along an edge ofsaid inferior skirt.
 10. The device as set forth in claim 2 furthercomprising a superior and inferior collar anterior said nipple bulb,said superior collar set anterior of said inferior collar.
 11. Thedevice as set forth in claim 10, wherein said superior collar is set 1-3mm anterior said inferior collar.
 12. The device as set forth in claim 6wherein said superior skirt comprises at least two separable ribsemanating from said collar to an edge of the skirt.
 13. The device asset forth in claim 12 wherein each of said ribs comprise a minorundulation between said collar and said edge, and said major undulationforming a bumper along said edge.
 14. The device as set forth in claim 6further comprising a one-way valve within said nipple preventing fluidflow anterior of a pore on said bulb.
 15. A method for providing lateralpressures on the maxilla via an intra-oral device, said methodcomprising: a. at least partially inserting a nipple with a first rightpad and second left pad along a superior side of the nipple; b. pressinga tongue against a tongue guide along an inferior side of the nipplecausing a first and second pad to separate laterally from one another;c. engaging the maxillary palate with the pads to cause an outwardlateral force to the palate via the pads.
 16. The method as set forth inclaim 15 further comprising the steps of: d. forcing fluid from a bottleinto live nipple; and e. elevating the pressure within a nipple chamber.17. The method as set forth in claim 16 further comprising the steps ofextending a skirt outwardly from a nipple collar at an angle ofapproximately twenty degrees from vertical.
 18. The method as set forthin claim 17 further comprising the step of extending the nippleposteriorly during said step of pressing, causing the pads to migrateposteriorly into the oral cavity.
 19. The method as set forth in claim16 further comprising the step of causing rhythmic vibrational signalingthrough the shell to an oral surface during said step of pressing. 20.The method as set forth in claim 15 whereby said step of pressingfurther comprises the step of locating a portion of the tongue anteriorof a posterior ridge to cause an anterior force to pull the mandibleforward relative the maxilla.